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Pexidartinib (Turalio®) is used to treat tenosynovial giant cell tumor (TGCT).

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Page 1 PEXIDARTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name Pexidartinib (pex I DAR ti nib) Brand name Turalio® (tur a lee oh) Approved uses Pexidartinib is used to treat tenosynovial giant cell tumor (TGCT). Dose and schedule Taking pexidartinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of pexidartinib is 400 milligrams (400 mg) to be taken by mouth at a scheduled time twice a day. Pexidartinib should be taken on an empty stomach (one hour before or two hours after a meal or snack) and at the same time each day. Pexidartinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow pexidartinib, talk to your care provider or pharmacist for possible options. If you miss a dose of pexidartinib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose, and let your care provider know about any missed doses.” Drug and food interactions Pexidartinib has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with pexidartinib; avoid eating or drinking this during treatment with pexidartinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Pexidartinib should be taken without food. Medications that decrease stomach acid may decrease pexidartinib concentrations. Avoid use with proton pump inhibitors (e.g., omeprazole [Prilosec®], esomeprazole [Nexium®]), if possible. As an alternative, you may use an antacid or a histamine blocker if separated from pexidartinib. If taken with a histamine blocker (e.g., ranitidine [Zantac®], famotidine [Pepcid®]), take pexidartinib 10 hours after the histamine blocker and at least 2 hours prior to the next histamine blocker dose. If taken with an antacid (e.g. calcium carbonate [Tums®], aluminum hydroxide, [Rolaids®]), take pexidartinib 2 hours before or 2 hours after the antacid.” PEXIDARTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle pexidartinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store pexidartinib at room temperature (68°F–77°F) in a dry location away from light. Keep pexidartinib out of reach of children and pets. Leave pexidartinib in the provided packaging until it is ready to be taken. Whenever possible, you should give pexidartinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the pexidartinib to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the pexidartinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box or pill reminder is not recommended to be used with pexidartinib. If you have any unused pexidartinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of pexidartinib. If you are traveling, put your pexidartinib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. PEXIDARTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Pexidartinib Below are common side effects that have been known to happen in about one third or more of patients taking pexidartinib; these are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Unusual bleeding or bruising Hair color changes Changes to your hair color may occur during treatment. The hair usually returns to normal after treatment, but for some, this change is permanent. Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever (temperature more than 100.4°F or 38°C) Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Continued on the next page PEXIDARTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Increased cholesterol levels Changes in cholesterol may occur and will be monitored by a simple blood test. You may not feel any symptoms if changes occur. Your care team will monitor for this. Eye changes This medication may cause eye swelling in or around your eyes, blurred vision, or eye pain. Report changes in eyesight to your care provider. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: Choose and prepare foods that look and smell good to you. Use plastic utensils if food tastes like metal. Flavor foods with spices to change taste. Suck on mints or chew gum to mask taste. Brush teeth before and after eating with a soft bristle toothbrush. Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. PEXIDARTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Serious side effects If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since pexidartinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take pexidartinib, it is important to adhere to the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or pexidartinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking pexidartinib. Females of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 month after the last dose of pexidartinib. Males should use effective contraception during therapy and for a minimum of 1 week after the last dose of pexidartinib. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking pexidartinib and for 1 week after the last dose of pexidartinib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care team for assistance. PEXIDARTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved. Obtaining medication Talk with your care provider about the process for obtaining your pexidartinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: Product prescribing information: docs/ label/2019/211810s000lbl.pdf?utm campaign=FDA%20approves%20new%20therapy%20for%20TGCT&utm medium=email&utm source=Eloqua Product resources: resources Updated – November 9, 2019 Additional instructions